Safety and Outcomes of Dabigatran Reversal With Idarucizumab Before IV Thrombolysis in Patients With Acute Ischemic Stroke.

Abstract (English)

BACKGROUND AND OBJECTIVES: IV thrombolysis (IVT) is contraindicated in patients with acute ischemic stroke (AIS) while on dabigatran or other oral anticoagulant (OAC) treatment. Idarucizumab completely reverses the effect of dabigatran within minutes, without increasing the risk of thromboembolism. Limited data exist on IVT treatment after dabigatran reversal with idarucizumab. We aimed to investigate the safety and outcomes of IVT after dabigatran reversal in patients with AIS. METHODS: This is an observational study based on the Safe Implementation of Treatment in Stroke (SITS) International Stroke Thrombolysis Registry. Hospitals treating patients with AIS contributed data. The main outcome was safety as measured by any parenchymal hematoma (PH), symptomatic intracerebral hemorrhage (SICH) per SITS, and death within 3 months. The secondary outcome was functional independence defined as modified Rankin Scale scores of 0-2 at 3 months. Propensity score matching (PSM) was used to compare patients treated with dabigatran reversal to patients without prior OAC in primary analysis and for secondary analysis between patients treated with dabigatran reversal with idarucizumab to patients on dabigatran without reversal treatment. RESULTS: Among 258,589 IVT treated patients with AIS, 510 were on dabigatran and 156 received dabigatran reversal. Dabigatran reversal patients were older (75 vs 69 years, <i>p</i> < 0.01), had similar median baseline NIH Stroke Scale (9 vs 10, <i>p</i> = 0.47), and longer onset to IVT time (185 vs 150 minutes, <i>p</i> < 0.01) compared with patients without prior OAC treatment (n = 191,648). After PSM analysis where good balance was achieved, patients treated with dabigatran reversal before IVT had similar results in all outcomes as compared with patients treated with IVT without prior OAC (any PH: 3 vs 9%, <i>p</i> = 0.10; SICH: 1 vs 1%, <i>p</i> = 1.00; death: 25 vs 19%, <i>p</i> = 0.33, functional independence: 51 vs 52%, <i>p</i> = 0.95). Secondary analysis showed similar results for all outcomes before and after PSM. DISCUSSION: In our observational study with patients with AIS, IVT treatment after dabigatran reversal was safe and had similar outcomes to IVT treatment without previous OAC. Furthermore, comparison between dabigatran reversal vs no reversal also indicates that IVT is safe for patients on dabigatran without idarucizumab reversal, which is currently being investigated in clinical trials. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that IVT after idarucizumab reversal in patients with AIS who took dabigatran within 48 hours of onset of symptoms is safe and comparable with those of patients with AIS not on prior oral anticoagulation.